Controlled Diabetes, Controlled Hypertension, Healthy Adult Participants
Conditions
Keywords
App-based exercise, personalized exercise, middle aged adults, older adults
Brief summary
The purpose of this study is to investigate the effectiveness and usability of a Gingko app based exercise training in middle and older aged adults. The main question it aims to answer is if the personalized Gingko app-based exercise is more effective in improving overall physical function than self-guided training with the NIA exercise booklet.
Detailed description
Individuals aged \>45 years will be recruited. All participants will complete app-based and other assessments at 3 time points(baseline, 6 weeks into the intervention, and after 12 weeks of intervention). Each participant will be asked to perform 3-4 sessions of exercise per week for 12 weeks. Participants will be randomly assigned to receive either the Gingko app-based exercise raining or NIA booklet based exercise training. The following assessments will be performed: App-based physical assessments of strength, aerobic capacity, and balance, International Physical Activity Questionnaire (IPAQ) to assess physical activity levels, Short Form-12 (SF-12) to assess the quality of life ,Likert scale ratings and open-ended questions to assess user satisfaction and acceptability, Self-Efficacy Exercise Scale (SEE) to assess patient reported exercise self-efficacy.
Interventions
COMBINATION_PRODUCTGinkgo App-based Exercise Training
Participants in this group will receive personalized exercises from Ginkgo App
COMBINATION_PRODUCTNIA Booklet Exercise
Participants in this group will first receive NIA booklet based exercise. After 12 weeks, they will crossover to the experimental group to receive personalized personalized exercises from Ginkgo App
Sponsors
University of Maryland, Baltimore
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Age ≥ 45 years * Independent community ambulation with or without straight cane * Able to follow 3 step commands * WiFi access at home
Exclusion criteria
* Medical contraindications to exercise (including terminal illness, uncontrolled arrhythmias, recent myocardial infarction, unstable angina, unstable cardiovascular disease or other unstable medical condition) * Significant musculoskeletal or neurological disorders as indicated by limitations in activities of daily life (i.e., \<6 score on the Katz Index) * Participation in other clinical trial within 6 weeks
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| App-based physical assessments of strength | Change from baseline physical assessment at 12 weeks | The Ginkgo Active app will instruct and guide participants through a standardized upper-body, lower-body, and core exercise, measuring strength by repetitions completed within a set time or by the duration a position is held (based on the exercise and muscle group being tested) |
| App-based physical assessments of endurance | Change from baseline physical assessment at 12 weeks | The Ginkgo Active app will instruct and guide participants through an endurance assessment using the Step-in-Place test. The participant stands upright next to a wall and positions one hand at a height midway between the patella (kneecap) and the iliac crest (top of the hip bone). The participant then marches in place for a specified duration, lifting the knees to the height of the hand. Rest breaks are permitted, and participants may hold onto the wall or a stable chair for balance. Endurance is assessed by recording the total number of times the right knee reaches the target hand height |
| App-based physical assessments of balance | Change from baseline physical assessment at 12 weeks | The Ginkgo Active app will instruct and guide participants through a balance assessment using the single-leg stance test. Participants will be asked to maintain balance on one leg for up to 30 seconds. Performance is interpreted as follows: holding the position for less than 10 seconds indicates a need for balance training, whereas maintaining the position for 25-30 seconds indicates good, stable balance. |
| Weight Measurement | Change from baseline physical assessment at 12 weeks | The weight will measured in kilograms |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| International Physical Activity Questionnaire (IPAQ) | Change from Baseline IPAQ score at 12 weeks | The IPAQ is a 27-item self-reported measure of physical activity. The IPAQ assesses physical activity (walking, moderate \& vigorous activity, sitting) over the last 7 days, generating scores as Metabolic Equivalent (MET)-minutes per week (continuous) or by categorizing into low, moderate, or high activity levels (categorical). Scoring involves multiplying minutes per week for each activity type by assigned MET values (e.g., 8 for vigorous, 4 for moderate, 3.3 for walking) and summing them for total MET-minutes, then applying specific criteria for categories like minimum days/duration. |
| Short Form-12 (SF-12) | Change from Baseline SF-12 at 12 weeks | The SF-12 (Short Form-12) is a 12-item questionnaire measuring physical and mental health quality of life, yielding two key scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Scoring uses a norm-based method, where scores around 50 represent the U.S. average, with a standard deviation of 10 (e.g., 60 is one SD above average, 40 is one SD below). Higher scores generally indicate better perceived health and function, reflecting underlying domains like physical functioning, pain, vitality, and mental health. |
| Participant Acceptability and Satisfaction | At the end of 12 weeks | Participant-reported satisfaction, comfort, and ease of use assessed using a 5-point Likert scale and open-ended qualitative feedback.A Likert scale is a rating scale used in surveys to measure opinions, attitudes,and perceptions by asking respondents to indicate their level of agreement or disagreement with a statement. It consists of a series of statements with a symmetric range of response options, such as a five-point scale from 0="Strongly Disagree" to 5="Strongly Agree". This method allows for the collection of quantitative data to analyze subjective experiences. |
| Self-Efficacy Exercise Scale (SEE) | Change from Baseline SEE score at 12 weeks | The Self-Efficacy Exercise Scale (SEE) assesses confidence in exercising despite barriers, typically with 9 items asking how confident you are (0-10 scale) to exercise 3x/week for 20 mins. Scoring involves summing responses (0-90 total) or averaging (0-10 score), with higher scores indicating greater self-efficacy. |
Contacts
PRINCIPAL_INVESTIGATORKelly Westlake, PhD
University of Maryland, Baltimore
Outcome results
None listed